An observational study in Dry Needling, sponsored by Youngstown State University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by Youngstown State University · Observational
As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention. The adverse events are important to consider when an individual needs to make an informed decision regarding their care. It is important to consider how such information should be presented during the informed consent process to improve an individual's ability to make a sound decision regarding their own personal care.
Dry Needling (DN) has been defined by a Task Force organized by the Federation of State Boards of Physical Therapy (FSBPT) as "a skilled intervention performed by a physical therapist using filiform needles to penetrate the skin and/or underlying tissues to affect change in body structures and functions for the evaluation and management of neuromusculoskeletal conditions, pain, movement impairments, and disability". As DN interest continues to expand and studies continue to show the feasibility of applying DN to a wider range of pathological conditions, there is a need to understand the risks related to the use of DN. Understanding the risks associated with DN will allow for improvements in clinical decision making regarding it's application in the clinic.
Enhancing patient choice is a central theme of medical ethics and law. Informed consent (IC) is the legal process used to promote patient autonomy while concepts of shared decision making (SDM) is a widely promoted ethical approach. IC is a means of respecting the autonomous preferences of persons seeking health care or participation in research. Empowerment of the patient is important in healthcare and can lead to improvements in overall quality of patient care and outcomes.
To date, there has been little research conducted that explored the topic of how risks should be presented during the IC process. The purpose of this study will be to utilize expert consensus to establish a risk statement for adverse events associated with DN that an be used during IC.
Youngstown State University is the lead sponsor of 29 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Dry Needling Experts, Legal Experts, Policy Experts, and Patients (Defined with inclusion criteria above).
Participants must be 18 years old or above and be able to read/write in English Participants must provide informed consent Participants must meet the criteria of one of the previously defined cohort groups used in the study
Dry Needling Experts
(1) Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:
Legal Expert
An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria:
Training in health law as evidenced by ONE of the following:
An individual who has a degree in bioethics with at least ONE of the following criteria:
Patient Must have participated in >= 1 session of dry needling treatment and not be a healthcare provider
Exclusion Criteria:
Participants who did not provide informed consent Participants who did not meet the inclusion criteria of one of the four cohort groups defined in the study.
Must have participated in \>= 1 session of dry needling treatment and not be a healthcare provider.
Other: Nominal Group Technique - 2 to 3 hour virtual meeting
(1) Must have \>= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria: 1. Certification in Dry Needling 2. Completion of a manual therapy fellowship that included dry needling training 3. \>= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling
Other: Nominal Group Technique - 2 to 3 hour virtual meeting
An individual who has a degree in bioethics with at least ONE of the following criteria: 1. \>= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics 2. Has served on ethics related committee in a healthcare institution or healthcare society/professional association 3. Is or has been a member of a state licensing board
Other: Nominal Group Technique - 2 to 3 hour virtual meeting
An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria: 1. Evidence of training based on ONE of the follow: 1. Concentration/Certification in Health Law 2. L.L.M in health or medical law 3. SJD in health law 2. Experience in litigating medical malpractice cases involving failure to obtain informed consent 3. Published scholarship on informed consent in an academic journal (\>= 1)
Other: Nominal Group Technique - 2 to 3 hour virtual meeting
Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.
Demographic Information Form
Contains questions about the characteristics of the participants
Time frame: Up to 2 hours
Ranking of Statements
Participants will rank statements generated during the meeting to determine which statement best meets consensus within the group
Time frame: A 2 hour virtual meeting for participants to rank statements
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Youngstown State University